2. WHO IS RESPONSIBLE FOR DEVELOPING THE ISO 9000 STANDARDS?

ISO 9001:2008 FAQ IAS Pvt Ltd., Reference : www.iasiso.com 1. WHAT ARE THE ISO 9000 STANDARDS ? The ISO 9000 standards are a collection of formal In...
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ISO 9001:2008 FAQ IAS Pvt Ltd.,

Reference : www.iasiso.com

1. WHAT ARE THE ISO 9000 STANDARDS ? The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis. (It should be noted that many of the International Standards in the ISO 9000 family are numbered in the ISO 10000 range.) 2. WHO IS RESPONSIBLE FOR DEVELOPING THE ISO 9000 STANDARDS ? ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees, are responsible for the development of the standards. The work is conducted on the basis of "consensus" among quality and industry experts nominated by the National Standards Bodies, representing a wide range of interested parties.

3.WHERE CAN COPIES OF THE SUPPORTING ISO 9000 GUIDANCE NOTES OR OTHER DOCUMENTS BE FOUND ? Copies of the ISO 9000 Introduction and Support Package modules: Guidance on ISO 9001:2008 Sub-clause 1.2 'Application' Guidance on the Documentation Requirements of ISO 9001:2008 Guidance on the Terminology used in ISO 9001 and ISO 9004 Guidance on the Concept and Use of the Process Approach for management systems Guidance on 'Outsourced Processes' as well as details of the Quality Management Principles can be found at: www.iso.org/tc176/sc2. Copies of the ISO 9001 Auditing Practices Group guidance notes. Copies of the sanctioned ISO/TC 176 sanctioned "Interpretations" of ISO 9001 can be found at: http://www.tc176.org/

ISO 9001:2008 FAQ IAS Pvt Ltd.,

Reference : www.iasiso.com

4. WHERE CAN INFORMATION BE OBTAINED ON THE ISO 9000 STANDARDS ? There are a number of sources of information on the ISO 9000 quality management system standards, including ISO's web site (www.iso.org), which carry information on the standards. Your National Standards Body should be able to provide copies of the standards, and registrars/certification bodies will be able to provide guidance on registration arrangements.

5.WHAT ARE THE BENEFITS OF THE REVISED STANDARDS ? For ISO 9001:2008 the major benefits are: Simple to use Clear in language Readily translatable and easily understandable Compatibility with other management systems such as ISO 14001. For ISO 9004 : Facilitates improvement in users' quality management systems. Provides guidance to an organization for the creation of a quality management system that: - creates value for its customers, via the products it provides - creates value for all other interested parties - balances all interested-party viewpoints. - Provides guidance for managers on leading their organization towards sustained success. - Forward compatibility to allow organizations to build on existing quality management systems. 6. WHAT ARE THE MAIN CHANGES IN ISO 9001:2008 ? ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. Certification to ISO 9001:2008 is not an "upgrade", and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO 9001:2008.

ISO 9001:2008 FAQ IAS Pvt Ltd.,

Reference : www.iasiso.com

10. WHAT DOES AN ORGANIZATION NEED TO DO TO COMPLY WITH ISO 9001 ? When initially starting to use ISO 9001, an organization should familiarize its personnel with the Quality Management Principles, analyze the standards (especially ISO 9000 and ISO 9004), and consider how their guidance and requirements may affect your activities and related processes. If it then wishes to proceed to registration/certification, it should perform a gap analysis against the requirements of ISO 9001 to determine where its current quality management system does not address the applicable ISO 9001:2008 requirements, before developing and implementing additional processes to ensure that compliance will be achieved.

11. WHAT WILL HAPPEN TO THE 2000 VERSION OF ISO 9001 ? ISO 9001:2008 will supersede ISO 9001:2000 However, noting the IAF/ISO-CASCO/ISO TC176 agreement that accredited certification to the 2000 edition should remain possible for up to 2 years after the publication of ISO 9001:2008, copies of the 2000 edition will still be available on request from ISO and the national standards bodies during that period, and possibly for even longer.

12. WHAT WILL HAPPEN TO THE OTHER STANDARDS AND DOCUMENTS IN THE CURRENT (2000) ISO 9000 FAMILY ? The four primary standards of the current ISO 9000 family are the following: ISO 9000:2005 already published - no major changes expected for 2009 ISO 9001:2000 to be superseded by ISO 9001:2008 More significant changes are planned for ISO 9004 with a planned publication date of late 2009. ISO 19011:2002 is currently beginning the revision process, with a new version expected in 2011. The other standards and documents will be reviewed and updated as necessary

ISO 9001:2008 FAQ IAS Pvt Ltd.,

Reference : www.iasiso.com

13. HOW SOON CAN MY ORGANIZATION SEEK CERTIFICATION TO ISO 9001:2008 ? ISO 9001: 2008 certificates can only be granted after its publication as an International Standard.

14. WILL I BE ABLE TO CERTIFY/REGISTER MY ORGANIZATION TO ISO 9004:2009 ? Since ISO 9004:2009 will be a guidance document, it is not intended to be used for third party certification purposes.

15. MY ORGANIZATION IS THINKING ABOUT DEVELOPING A QUALITY MANAGEMENT SYSTEM TO ISO 9001. SHOULD WE WAIT UNTIL THE REVISED STANDARDS ARE PUBLISHED ? No, you should not delay the introduction of the quality management system in your organization. Like those who are currently in the process of being registered/certified, anything you do now to lay the foundation of a quality management system within your organization will be beneficial.

16. MY ORGANIZATION IS APPLYING FOR ISO 9001 CERTIFICATION IN 2008. WHAT SHOULD I DO ? Organizations in the process of certification to ISO 9001:2000 are recommended to apply for certification to ISO 9001:2008, as soon it is published. Up to its publication you can still apply for certification to ISO 9001:2000.

17. CAN AN ORGANIZATION BE CERTIFIED/REGISTERED TO ISO 9004 ? ISO 9004 is a guidance standard, which is not intended to be used for third party registration/certification purposes. A key element of ISO 9004 is the ability to perform self-assessments. Third party quality management system certifications/ registrations are performed to ISO 9001:2008.

ISO 9001:2008 FAQ IAS Pvt Ltd.,

Reference : www.iasiso.com

18. IS AN ORGANIZATION'S ISO 9001 CERTIFICATE APPLICABLE TO ALL OF ITS PRODUCTS ? When an organization seeks to have its quality management system registered/certified to ISO 9001:2008, it is required to agree a "scope of certification" with its registrar/certification body. This will define the products to which the organization's quality management system is applicable, and against which it will be assessed. An organization is not obliged to include within its "scope of certification" all the products that it provides (note that the ISO 9000:2005 definition of "Product" includes "services"), but may be selective about those that are included. All applicable requirements of ISO 9001:2008 will need to be addressed by the organization's quality management system that covers those products that are included in the "scope of certification". Customers should ensure that a potential supplier's "scope of certification" covers the products that they wish to order. Caveat Emptor!

19. WHAT CAN AN ORGANIZATION DO IF IT IS NOT ABLE TO COMPLY WITH ALL OF THE REQUIREMENTS OF ISO 9001? ISO 9001 allows for the exclusion of some of its requirements (via clause 1.2 "Application"), but only if it can be shown that these requirements are not applicable to the organization. Exclusions are limited to the requirements given in Section 7 ("Product Realization"), where individual requirements may only be excluded if it can be shown that they do not affect the organization's ability to provide product that meets customer and applicable statutory or regulatory requirements. Justification for such exclusions is also required to be detailed within the organization's quality manual. For example, if design activities are not required by an organization to demonstrate its capability to meet customer and applicable statutory /regulatory requirements, or if its product is provided on the basis of established design, then it may be able to exclude some of the "design" requirements but still be able to be registered/certified to ISO 9001:2008. For further guidance, see the ISO 9000 Introduction and Support Package module: Guidance on ISO 9001:2008 clause 1.2 'Application'.

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